Since my post yesterday, a number of readers pointed out that the DMF assessment requirement as a basis for Refuse-to-Receive file determination has been removed from the previous guidance. I concur that is the case, and there are and may be multiple reasons for its removal.
The newly revised Refuse-to-Receive (RTR) Guidance for ANDAs was issued on May 26, 2015 and was published on the FDA website the same day.
There are certain products that must be Q1 (qualitatively) and Q2 (quantitatively) the same, in terms of active and inactive ingredients, in order to avoid having to conduct in vivo pharmacokinetic or bioequivalence studies with clinical endpoints.
The FDA posted its activity associated with the some unregistered wholesalers that target doctors’ offices and clinics offering discount drugs. In addition, FDA has sent letters to doctors and clinics that may have purchased counterfeit or unapproved drugs.
With June 15th quickly approaching, the industry is preparing to discuss the progress under GDUFA I with FDA while also being able to extol the successes and shortcomings of the first iteration of GDUFA.
As we reported in October of 2014, the FDA announced that it was proposing to conduct a study of pharmacist and patient perception of changes in the physical attributes of generic products.
Remember the problem associated with the evergreening of patents, which was the practice of obtaining and listing newly issued patents sequentially, and the resultant multiple 30-month stays that essentially kept generics off the market for prolonged periods of time?
FDA today released a draft Guidance document entitled, “Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.”
The FDA has published a Federal Register Notice announcing the reopening of the administrative record on the Tentative Final Monograph (TFM) for Topical Antimicrobial Drug Products for Over-the-Counter Human Use.
The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.
The Office of Generic Drugs (OGD) posted its latest paragraph IV listings and, while there was only one new addition to the list, that product caught my attention.
In the Federal Register today, FDA announced a public meeting to be held on June 15, 2015 at the FDA’s White Oak campus. The purpose of the meeting is to get the public’s input on the potential reauthorization of the Generic Drug User Fee Act (GDUFA).
The FDA is warning about some counterfeit Botox that has been found in the United States. The product looks similar to the brand name product but “[B]oth the outer carton and vial on the suspect product are counterfeit.
The date to comment is being extended to June 8, 2015, based on requests from the industry for more time to digest the Rule.
There are so many issues covered by the Proposed 505(b)(2) and ANDA Rule that we can fill a book with the explanations (and we almost have). But we are giving you the Readers Digest condensed version in these posts. Be certain to read the entire Proposed Rule and watch for comments on Regulations.gov to get an idea of which sections will provide more controversy than others.